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Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty

Primary Purpose

Total Knee Arthroplasty, Pain, Postoperative, Adductor Canal Block

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Multimodal Peripheral Nerve Block Injection
Single Shot Adductor Canal Block
Initial Bolus
Continuous infusion
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients will be eligible for inclusion in the study if they are:

  • Age of 18 years old or older
  • Scheduled to primary unilateral total knee arthroplasty.
  • Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment

Exclusion Criteria:

Patients will be excluded if they have:

  • A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal.
  • Poorly controlled diabetes (A1C >8.0)
  • Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone)
  • Opioid use >40 mg of oxycodone daily, long-acting opioids.

Sites / Locations

  • Wake Forest Baptist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Continuous adductor canal block

Single injection block with sham cath

Arm Description

After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour. Multimodal peripheral nerve block injection.

Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.

Outcomes

Primary Outcome Measures

Pain scores
At 30 hours pain scores between the two groups will be compared for determining statistically significant differences

Secondary Outcome Measures

total opioid consumption
The amount of total opioid consumed will be collected

Full Information

First Posted
December 8, 2016
Last Updated
April 3, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02991404
Brief Title
Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
Official Title
Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either multimodal single injection adductor canal block with sham infusion catheter or continuous infusion of local anesthetic (control) for postoperative analgesia. Primary end point is pain scores at 30 hours post performance of block procedure.
Detailed Description
The objective of this study is to determine if a single shot multimodal peripheral nerve block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will provide comparable (equivalent) analgesic control when compared to an adductor catheter. The primary end point will be pain scores at 30 hours post block initiation. Secondary end points will include, opioid consumption, time to first analgesic request; pain scores; binary patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative nausea, and vomiting. Methods and Measures Design The study will be a randomized, double-blind, sham catheter study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm" receive a single shot adductor canal block containing 20 milliliters (ml) of solution including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm. The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in the current pump in use at our hospital). An opaque bag will be placed over the pump for blinding purposes. The "Control Arm" will receive an adductor canal catheter through which they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will be placed over the control arm pumps in similar fashion. For all patients, the order in the electronic medical record will be per research pharmacy protocol. For their primary anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic or general anesthetic per the anesthesiologist in the operating room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Pain, Postoperative, Adductor Canal Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous adductor canal block
Arm Type
Active Comparator
Arm Description
After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour. Multimodal peripheral nerve block injection.
Arm Title
Single injection block with sham cath
Arm Type
Sham Comparator
Arm Description
Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.
Intervention Type
Procedure
Intervention Name(s)
Multimodal Peripheral Nerve Block Injection
Other Intervention Name(s)
adductor canal catheter bolus and continuous infusion
Intervention Description
After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
Intervention Type
Procedure
Intervention Name(s)
Single Shot Adductor Canal Block
Other Intervention Name(s)
adductor canal block
Intervention Description
A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.
Intervention Type
Drug
Intervention Name(s)
Initial Bolus
Intervention Description
20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine
Intervention Type
Drug
Intervention Name(s)
Continuous infusion
Intervention Description
Continuous infusion of 0.125% bupivacaine
Primary Outcome Measure Information:
Title
Pain scores
Description
At 30 hours pain scores between the two groups will be compared for determining statistically significant differences
Time Frame
30 hours post block placement
Secondary Outcome Measure Information:
Title
total opioid consumption
Description
The amount of total opioid consumed will be collected
Time Frame
Through 30 hours post block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for inclusion in the study if they are: Age of 18 years old or older Scheduled to primary unilateral total knee arthroplasty. Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment Exclusion Criteria: Patients will be excluded if they have: A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal. Poorly controlled diabetes (A1C >8.0) Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone) Opioid use >40 mg of oxycodone daily, long-acting opioids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Jaffe, D.O.
Organizational Affiliation
Dr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty

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